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Gene Testing Questioned by Regulators

Regulators are cracking down on companies that sell genetic tests directly to consumers, threatening to crimp the growth of one of the hottest sectors of the biotechnology industry.

The California Department of Public Health sent “cease and desist” letters to 13 genetic testing companies two weeks ago, telling them they could not solicit business from state residents. The companies include the early leaders in the field — 23andMe, Navigenics and deCode Genetics — which are trying to carve out a new business of offering personal genetic information for use in health and lifestyle planning.

The California action follows efforts by New York State, which has sent letters to 31 genetic testing companies since November, saying they need licenses to solicit DNA specimens from the state’s residents.

Pressure is also mounting for the federal government to take more action. A report in April by a federal advisory committee said there were significant gaps in the oversight of genetic tests that could lead to patient harm. The Department of Health and Human Services will hold a two-day public meeting July 7 and 8 to discuss regulation of personal genetic information services.

The Federal Trade Commission, meanwhile, has started investigations into possibly deceptive advertising or marketing of genetic tests, according to an agency official who spoke at a June 12 meeting convened by Senator Gordon Smith. The senator, an Oregon Republican, has been prodding federal agencies to take a stronger stance in overseeing genetic tests sold to consumers.

Yet the move to regulate the tests is raising many issues. What are the standards for proving a genetic test is valid? Must a doctor always be involved in ordering such tests to protect patients, or is that an attempt by doctors to protect their turf?

Some of the companies say people have a right to know the information in their genes and to guide their own health care.

“We think your genetic information is a fundamental part of you,” said Anne Wojcicki, a co-founder of 23andMe. The company, based in Mountain View, Calif., has attracted attention not only because of its $1,000 genome testing service but because it is partly financed by Google and because Ms. Wojcicki is married to the Google co-founder Sergey Brin.

Navigenics and 23andMe say they are not offering medical testing, but rather personal genetic information services. Using a saliva sample, they scan a person’s genome at multiple points looking for variations that might indicate a person is at a higher than normal risk for certain diseases.

“This doesn’t say you have a disease,” said Mari Baker, the chief executive of Navigenics, which is based in Redwood Shores, Calif., and whose service costs $2,500. “It says you carry a genetic predisposition for the disease and should talk with a health care professional.”

But not everyone agrees with that rationale.

“We think if you’re telling people you have increased risk of adverse health effects, that’s medical advice,” said Ann Willey, director of the office of laboratory policy and planning at the New York State Department of Health.

Genetic tests that are developed by clinical laboratories generally do not require approval by the Food and Drug Administration before they can be marketed.

The laboratories themselves are regulated by the Centers for Medicare and Medicaid Services. Such regulation is meant to ensure that laboratories are proficient and that the tests are “analytically valid.” That means that if a test purports to detect a particular genetic variation, it does so reliably.

But critics say such regulation does not assure that tests are “clinically valid” — that having a particular genetic variation actually means a person has a disease or is at risk for one. Critics also say many tests now being sold to consumers are not backed by adequate scientific studies.

The California letters, sent on June 9 and 10, said the companies needed to have state licenses as clinical laboratories. In addition, they said, genetic tests could be ordered only by a doctor, not by consumers.

“We started this week by no longer tolerating direct-to-consumer genetic testing in California,” Karen L. Nickel, chief of laboratory field services for the state health department, said during a June 13 meeting of a state advisory committee on clinical laboratories.

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Lea Brooks, a spokeswoman for the health department, said the letters were sent in response to consumer complaints about the cost and accuracy of the tests.

Most of the attention so far has focused on Navigenics and 23andMe because of their high profiles and the fact that they acknowledged getting the state’s letters. The identities of most of the other recipients were unknown until Tuesday, when the state health department posted all 13 letters on its Web site.

The other recipients include Knome, which is offering to do a complete sequence of a person’s genome for $350,000.

Also on the list were a few companies that give diet advice based on a person’s genes (and in some cases also sell dietary supplements). There were also some companies that offer genetic tests for single conditions, like the risk of baldness or Alzheimer’s disease.

The companies had until this Monday or Tuesday to respond to the agency, which will now review the responses.

At least one company that received a letter, Sciona, has stopped offering its gene testing and related diet advice to residents of California and New York. DeCode’s Web site indicates that certain calculations of disease risk will not be available to residents of New York, California and several other states.

But Navigenics and 23andMe say they believe they comply with the regulations and are continuing to accept samples from Californians. Navigenics has stopped accepting orders from New York while its laboratory seeks a state license. But 23andMe said it continues to accept orders from New York.

Both companies say they do not need a license from California because the genome scans are actually performed by outside laboratories that do have state licenses.

Navigenics said its tests are ordered by a physician because a doctor on contract to the company reviews customer orders before the specimens are passed to the testing laboratory.

But Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, said that “some doc on the payroll at Genes R Us” is not the same as a personal physician.

Dr. Hudson said it was “not surprising that the states are stepping in, in an effort to protect consumers, because there has been a total absence of federal leadership.” She said that if the federal government assured tests were valid, “paternalistic” state laws could be relaxed “to account for smart, savvy consumers” intent on playing a greater role in their own health care.